What is the generic name for Pradaxa (dabigatran etexilate)?

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Generic Name for Pradaxa

The generic name for Pradaxa is dabigatran etexilate. 1, 2

Key Pharmacological Details

Dabigatran etexilate is a prodrug that rapidly converts to its active form, dabigatran, which is the actual therapeutic agent. 1 This distinction is clinically important because:

  • Dabigatran itself is a highly polar molecule that cannot be absorbed from the gastrointestinal tract, necessitating the prodrug formulation for oral administration. 1

  • After oral absorption, dabigatran etexilate undergoes rapid ester cleavage by serine esterase enzymes (via two intermediates—BIBR 1087E and BIBR 951 CL) to produce the active dabigatran molecule. 1

  • The conversion process is independent of cytochrome P-450 enzymes, which significantly reduces the potential for drug-drug interactions compared to warfarin. 3

Mechanism of Action

Dabigatran functions as a selective, reversible, direct thrombin (factor IIa) inhibitor with a Ki of 4.5 ± 0.2 mM. 1 It works by:

  • Directly binding to the active site of thrombin through a salt bridge between its amidine group and Asp 189, along with hydrophobic interactions. 1

  • Acting as a univalent inhibitor that interacts only with the active site of thrombin, unlike hirudin derivatives that also bind to substrate recognition sites. 1

Clinical Nomenclature

In clinical practice and prescribing:

  • The brand name is Pradaxa® 1, 4, 5
  • The generic name is dabigatran etexilate 1, 2
  • The active metabolite is simply called dabigatran 1, 3

When prescribing or documenting, use "dabigatran etexilate" as the generic name, though clinicians often refer to it simply as "dabigatran" in shorthand, understanding that the oral formulation is necessarily the etexilate prodrug. 2, 5

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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